MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for 6FR ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, US N/A 610119 manufactured by Terumo Medical Corporation.
[188888800]
Expiration date - unknown due to unknown lot number. Udi - unknown due to unknown lot number. Implanted date: device was not implanted. Explanted date: device was not explanted. Device manufacture date - unknown due to unknown lot number. The actual device was not returned for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.
Patient Sequence No: 1, Text Type: N, H10
[188888801]
The user facility reported that the transition on the angio-seal device sheath to the arteriotomy locator is so big and bulky they cannot get it into the vessel. They aborted use and held manual pressure. There was no negative patient outcome or additional bleeding. Additional information was received on 11mar2020. The procedure outcome was successful, there was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013394970-2020-00201 |
| MDR Report Key | 9907717 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THERESA MUSSAW |
| Manufacturer Street | 950 ELKTON BLVD. |
| Manufacturer City | ELKTON, MD |
| Manufacturer Country | US |
| Manufacturer Phone | 2837866718 |
| Manufacturer G1 | TERUMO PUERTO RICO LLC |
| Manufacturer Street | INNOVACION STREET LOT 21 CAGUAS WEST INDUSTRIAL PARK |
| Manufacturer City | CAGUAS, 00725 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 00725 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 6FR ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, US |
| Generic Name | DEVICE, HEMOSTASIS, VASCULAR |
| Product Code | MGB |
| Date Received | 2020-03-31 |
| Model Number | N/A |
| Catalog Number | 610119 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO MEDICAL CORPORATION |
| Manufacturer Address | 265 DAVIDSON AVE SUITE 320 SOMERSET, NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |